PHARMACY LAW EXAM PRACTICE QUESTIONS AND CORRECT ANSWERS| A+
GRADED |GUARANTEED PASS!!
1) In Michigan, what schedules of controlled substances may pharmacists sell without a
prescription if the FDA allows it? How does this differ from federal law? - ANSWER In Michigan,
only non-prescription schedule 5 controls can be sold. Federal law allows non-prescription
schedules 2-5 though.
2) How much of a non-prescription schedule 5 controlled substance containing opium can be
dispensed in a 48-hour period? - ANSWER 240ml (8oz) or 48 dosage units
3) What does section 505B of the FDCA regulate? - ANSWER Human drug compounding within an
outsourcing facility
4) What does section 505A of the FDCA regulate? - ANSWER Human drug compounding by a
licensed pharmacist from a licensed U.S. pharmacy/federal facility or licensed physician for
patient use
5) True or false: In Michigan, compounding services may only be performed at a licensed pharmacy
or by a manufacturer. We do not allow outsourcing facilities. - ANSWER True
6) Can an outsourcing facility compound for patient-specific prescriptions? - ANSWER No
7) Under section 505A of the FDCA, you may not ship more than ____% of compounded drugs
outside of the state border. - ANSWER 5
8) What requirements must be met for a pharmacy to compound using bulk drug substances? -
ANSWER 1. Certificate of analysis of each substance
9) 2. The bulk substance was made by a facility registered with the FDA
10) 3. The bulk substance is part of an FDA-approved drug, has a USP monograph, or is on a list of
FDA-approved ingredients
,11) True or false: Compounding can occur using drugs that are withdrawn or removed from the
market. - ANSWER False
12) True or false: A pharmacist can compound a product in anticipation of receiving a prescription,
medical order, or dental order based on routine, regularly observed prescriptions or order
patterns. - ANSWER True
13) Is reconstituting or mixing a drug product following the package insert instructions considered
compounding? - ANSWER No
14) You are a pharmacist planning to add a flavoring agent to a commercial drug product. This would
not be considered compounding as long as you do not exceed _____% of the drug's total
volume. - ANSWER 5
15) In what situations would you be allowed to compound a commercially available, FDA-approved
product? - ANSWER 1. If there is a drug shortage and you can document proof of the drug
shortage at the time you perform the compounding.
16) 2. If you are producing a significant difference in the product from the commercially available
form, based on the professional judgement of the prescriber.
17) Michigan has adopted USP standards, if they are official compendium, for compounding. What
does official compendium mean? - ANSWER Official compendium is the September 30, 2014
version of USP/NF.
18) Assume a revision has just been made to the September 30, 2014 USP/NF for compounding. Are
these revisions official Michigan law compounding pharmacists must follow? If so, why? If not,
why not? - ANSWER No, revisions do not become official Michigan law until they are reviewed
(within 30 days) by LARA and the BOP and the decision is made to include the revision with
original compendium requirements.
19) Is USP 800 an enforceable chapter for state law? - ANSWER No, it is just an informational chapter
not adopted as a compendium itself. However, other oversight organizations like the Joint
Commission could enforce these standards for accreditation (separate from state agencies and
state laws)
,20) True or false: Disposal of hazardous medication requires a reverse distributor. - ANSWER True
21) May patients mail prescription drugs? - ANSWER No
22) Who is legally allowed to mail Rx-only drugs (assuming the drugs comply with Poison Prevention
Packaging)? - ANSWER Prescribers and pharmacists
23) May a patient mail an OTC medication? - ANSWER Yes, so long as it complies with the Poison
Prevention Packaging Act
24) You are a Michigan pharmacist who wants to mail controlled substances across state lines into
Ohio. What is required in order for you to be able to do this? - ANSWER You must be DEA-
registered in both states and have controlled substance licenses in each state.
25) How much of a non-prescription schedule 5 controlled substance not containing opium can be
dispensed in a 48-hour period? - ANSWER 120ml (4oz) or 24 dosage units
26) What must a non-prescription controlled substance be labelled with by the pharmacist? -
ANSWER Name and address of the patient (if the purchaser is not the patient you must also
include the name and address of the purchaser), name and quantity of the substance, date
purchased, name or initials of pharmacist or intern who dispensed the substance, and medical
purpose the substance was purchased (this is determined by the pharmacist)
27) True or false: If a drug does not go through the FDA approval process, it can be sold as a non-
prescription product even if the patient has a prescription written for it. - ANSWER True
28) What resources are available for us to use to determine if a medication went through the FDA
approval process or not to determine if it can be dispensed without a prescription? - ANSWER
DailyMed, IBM Micromedex Red Book, and Drugs@FDA
29) What is an example of a non-prescription schedule 5 controlled substance that can be
dispensed, what quantity can it be dispensed in, and why only this quantity? - ANSWER
Robitussin AC or Cheratussin AC (codeine phosphate/guaifenesin 10-100mg/5ml syrup), can only
, dispense 120ml or 24 dosage units because, in order to be able to dispense 240ml or 48 dosage
units, the product must contain raw opium, NOT an opium derivative.
30) What is the DEA's exempt prescription product list? - ANSWER A list of medications that are
normally controlled substances, but that exist in combination with certain ingredients or other
drugs or are in a certain dosage form that make them exempt from being controlled substances
according to the DEA.
31) True or false: LARA and the public will not know about the referral to HPRP or your participation
in HPRP unless you do not comply with the program or LARA was the one that referred you to
HPRP. - ANSWER True
32) What happens if you refuse to agree or not work with HPRP? - ANSWER HPRP officials must
close the case and inform LARA and the BOP because they have a duty to ensure the public's
safety
33) True or false: You are not a fully licensed pharmacist when you agree to enroll in the HPRP. -
ANSWER False, you are fully licensed, but depending on the monitoring agreement created by
HPRP you may have to agree to certain practice limitations
34) Where should the dispensing of non-prescription controlled substances be recorded? What must
be recorded? - ANSWER Records should be maintained and recorded in a bound record book,
this should include the name and address of the purchaser, the name and quantity of the
controlled substance purchased, the date of each purchase, and the name and initials of the
pharmacist who dispensed the substance
35) What are the list 1 chemicals (also known as scheduled listed chemical products or SLCPs)? -
ANSWER Pseudoephedrine, ephedrine, and phenylpropanolamine
36) How often must list one chemical sellers self-certify and pay their $21 fee to the DEA? - ANSWER
Annually
37) Where should list one chemicals be stored? - ANSWER Behind the counter where customers do
not have direct access
GRADED |GUARANTEED PASS!!
1) In Michigan, what schedules of controlled substances may pharmacists sell without a
prescription if the FDA allows it? How does this differ from federal law? - ANSWER In Michigan,
only non-prescription schedule 5 controls can be sold. Federal law allows non-prescription
schedules 2-5 though.
2) How much of a non-prescription schedule 5 controlled substance containing opium can be
dispensed in a 48-hour period? - ANSWER 240ml (8oz) or 48 dosage units
3) What does section 505B of the FDCA regulate? - ANSWER Human drug compounding within an
outsourcing facility
4) What does section 505A of the FDCA regulate? - ANSWER Human drug compounding by a
licensed pharmacist from a licensed U.S. pharmacy/federal facility or licensed physician for
patient use
5) True or false: In Michigan, compounding services may only be performed at a licensed pharmacy
or by a manufacturer. We do not allow outsourcing facilities. - ANSWER True
6) Can an outsourcing facility compound for patient-specific prescriptions? - ANSWER No
7) Under section 505A of the FDCA, you may not ship more than ____% of compounded drugs
outside of the state border. - ANSWER 5
8) What requirements must be met for a pharmacy to compound using bulk drug substances? -
ANSWER 1. Certificate of analysis of each substance
9) 2. The bulk substance was made by a facility registered with the FDA
10) 3. The bulk substance is part of an FDA-approved drug, has a USP monograph, or is on a list of
FDA-approved ingredients
,11) True or false: Compounding can occur using drugs that are withdrawn or removed from the
market. - ANSWER False
12) True or false: A pharmacist can compound a product in anticipation of receiving a prescription,
medical order, or dental order based on routine, regularly observed prescriptions or order
patterns. - ANSWER True
13) Is reconstituting or mixing a drug product following the package insert instructions considered
compounding? - ANSWER No
14) You are a pharmacist planning to add a flavoring agent to a commercial drug product. This would
not be considered compounding as long as you do not exceed _____% of the drug's total
volume. - ANSWER 5
15) In what situations would you be allowed to compound a commercially available, FDA-approved
product? - ANSWER 1. If there is a drug shortage and you can document proof of the drug
shortage at the time you perform the compounding.
16) 2. If you are producing a significant difference in the product from the commercially available
form, based on the professional judgement of the prescriber.
17) Michigan has adopted USP standards, if they are official compendium, for compounding. What
does official compendium mean? - ANSWER Official compendium is the September 30, 2014
version of USP/NF.
18) Assume a revision has just been made to the September 30, 2014 USP/NF for compounding. Are
these revisions official Michigan law compounding pharmacists must follow? If so, why? If not,
why not? - ANSWER No, revisions do not become official Michigan law until they are reviewed
(within 30 days) by LARA and the BOP and the decision is made to include the revision with
original compendium requirements.
19) Is USP 800 an enforceable chapter for state law? - ANSWER No, it is just an informational chapter
not adopted as a compendium itself. However, other oversight organizations like the Joint
Commission could enforce these standards for accreditation (separate from state agencies and
state laws)
,20) True or false: Disposal of hazardous medication requires a reverse distributor. - ANSWER True
21) May patients mail prescription drugs? - ANSWER No
22) Who is legally allowed to mail Rx-only drugs (assuming the drugs comply with Poison Prevention
Packaging)? - ANSWER Prescribers and pharmacists
23) May a patient mail an OTC medication? - ANSWER Yes, so long as it complies with the Poison
Prevention Packaging Act
24) You are a Michigan pharmacist who wants to mail controlled substances across state lines into
Ohio. What is required in order for you to be able to do this? - ANSWER You must be DEA-
registered in both states and have controlled substance licenses in each state.
25) How much of a non-prescription schedule 5 controlled substance not containing opium can be
dispensed in a 48-hour period? - ANSWER 120ml (4oz) or 24 dosage units
26) What must a non-prescription controlled substance be labelled with by the pharmacist? -
ANSWER Name and address of the patient (if the purchaser is not the patient you must also
include the name and address of the purchaser), name and quantity of the substance, date
purchased, name or initials of pharmacist or intern who dispensed the substance, and medical
purpose the substance was purchased (this is determined by the pharmacist)
27) True or false: If a drug does not go through the FDA approval process, it can be sold as a non-
prescription product even if the patient has a prescription written for it. - ANSWER True
28) What resources are available for us to use to determine if a medication went through the FDA
approval process or not to determine if it can be dispensed without a prescription? - ANSWER
DailyMed, IBM Micromedex Red Book, and Drugs@FDA
29) What is an example of a non-prescription schedule 5 controlled substance that can be
dispensed, what quantity can it be dispensed in, and why only this quantity? - ANSWER
Robitussin AC or Cheratussin AC (codeine phosphate/guaifenesin 10-100mg/5ml syrup), can only
, dispense 120ml or 24 dosage units because, in order to be able to dispense 240ml or 48 dosage
units, the product must contain raw opium, NOT an opium derivative.
30) What is the DEA's exempt prescription product list? - ANSWER A list of medications that are
normally controlled substances, but that exist in combination with certain ingredients or other
drugs or are in a certain dosage form that make them exempt from being controlled substances
according to the DEA.
31) True or false: LARA and the public will not know about the referral to HPRP or your participation
in HPRP unless you do not comply with the program or LARA was the one that referred you to
HPRP. - ANSWER True
32) What happens if you refuse to agree or not work with HPRP? - ANSWER HPRP officials must
close the case and inform LARA and the BOP because they have a duty to ensure the public's
safety
33) True or false: You are not a fully licensed pharmacist when you agree to enroll in the HPRP. -
ANSWER False, you are fully licensed, but depending on the monitoring agreement created by
HPRP you may have to agree to certain practice limitations
34) Where should the dispensing of non-prescription controlled substances be recorded? What must
be recorded? - ANSWER Records should be maintained and recorded in a bound record book,
this should include the name and address of the purchaser, the name and quantity of the
controlled substance purchased, the date of each purchase, and the name and initials of the
pharmacist who dispensed the substance
35) What are the list 1 chemicals (also known as scheduled listed chemical products or SLCPs)? -
ANSWER Pseudoephedrine, ephedrine, and phenylpropanolamine
36) How often must list one chemical sellers self-certify and pay their $21 fee to the DEA? - ANSWER
Annually
37) Where should list one chemicals be stored? - ANSWER Behind the counter where customers do
not have direct access
